The Kansas City District Office of the FDA submitted a recommendation of approval to the Center for Drug Evaluation and Research for The University of Iowa Pharmaceuticals (UIP) to manufacture an aseptically filled sterile, prescription drug product for a client. The drug product contains a new chemical entity and is a sterile solution that is aseptically filled into a vial. The FDA recommendation followed a Pre-Approval Inspection (PAI) of UIP’s facilities and procedures and review of the p...